BILL NUMBER: SB 585	CHAPTERED  07/06/99

	CHAPTER   70
	FILED WITH SECRETARY OF STATE   JULY 6, 1999
	APPROVED BY GOVERNOR   JULY 6, 1999
	PASSED THE ASSEMBLY   JUNE 24, 1999
	PASSED THE SENATE   MAY 17, 1999
	AMENDED IN SENATE   MAY 3, 1999

INTRODUCED BY   Senator Chesbro

                        FEBRUARY 23, 1999

   An act to amend Sections 1206.5, 1265, and 1300 of the Business
and Professions Code, relating to clinical laboratories.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 585, Chesbro.  Clinical laboratories.
   Existing law provides that clinical laboratory examinations
classified as physician-performed microscopy under specified federal
regulations governing clinical laboratories may be performed by
licensed physicians and surgeons, as specified.
   This bill would expand that category of persons who may perform
those clinical laboratory examinations to include licensed nurse
practitioners, licensed  physician assistants,  certified nurse
midwives, and licensed dentists.  The bill would also make technical
changes.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:


  SECTION 1.  Section 1206.5 of the Business and Professions Code is
amended to read:
   1206.5.  (a) Notwithstanding subdivision (b) of Section 1206, no
person shall perform a clinical laboratory test or examination
classified as waived under CLIA unless the clinical laboratory test
or examination is performed under the overall operation and
administration of the laboratory director, as described in Section
1209, including, but not limited to, documentation by the laboratory
director of the adequacy of the qualifications and competency of the
personnel, and the test is performed by any of the following persons:

   (1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
   (2) A licensed podiatrist or a licensed dentist when the results
of the tests can be lawfully utilized within his or her practice.
   (3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory.
   (4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code.
   (5) A licensed physician assistant when authorized by a
supervising physician and surgeon in accordance with Section 3502 or
Section 3535.
   (6) A person licensed under Chapter 6 (commencing with Section
2700).
   (7) A person licensed under Chapter 6.5 (commencing with Section
2840).
   (8) A perfusionist when authorized by and performed in compliance
with Section 2590.
   (9) A respiratory care practitioner when authorized by and
performed in compliance with Chapter 8.3 (commencing with Section
3700).
   (10) A medical assistant, as defined in Section 2069, when the
waived test is performed pursuant to a specific authorization meeting
the requirements of Section 2069.
   (11) A pharmacist, when ordering drug therapy-related laboratory
tests in compliance with clause (ii) of subparagraph (A) of paragraph
(5) of subdivision (a) of, or paragraph (6) of subdivision (a) of,
Section 4052.
   (12) Other health care personnel providing direct patient care.
   (b) Notwithstanding subdivision (b) of Section 1206, no person
shall perform clinical laboratory tests or examinations classified as
of moderate complexity under CLIA unless the clinical laboratory
test or examination is performed under the overall operation and
administration of the laboratory director, as described in Section
1209, including, but not limited to, documentation by the laboratory
director of the adequacy of the qualifications and competency of the
personnel, and the test is performed by any of the following persons:

   (1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
   (2) A licensed podiatrist or a licensed dentist when the results
of the tests can be lawfully utilized within his or her practice.
   (3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory.
   (4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code.
   (5) A licensed physician assistant when authorized by a
supervising physician and surgeon in accordance with Section 3502 or
Section 3535.
   (6) A person licensed under Chapter 6 (commencing with Section
2700).
   (7) A perfusionist when authorized by and performed in compliance
with Section 2590.
   (8) A respiratory care practitioner when authorized by and
performed in compliance with Chapter 8.3 (commencing with Section
3700).
   (9) A person performing nuclear medicine technology when
authorized by and performed in compliance with Article 6 (commencing
with Section 107115) of Chapter 4 of Part 1 of Division 104 of the
Health and Safety Code.
   (10) Any person when performing blood gas analysis in compliance
with Section 1245.
   (11) (A) A person certified as an "Emergency Medical Technician II"
or paramedic pursuant to Division 2.5 (commencing with Section 1797)
of the Health and Safety Code while providing prehospital medical
care, a person licensed as a psychiatric technician under Chapter 10
(commencing with Section 4500) of Division 2, as a vocational nurse
pursuant to Chapter 6.5 (commencing with Section 2840) of Division 2,
or as a midwife licensed pursuant to Article 24 (commencing with
Section 2505) of Chapter 5 of Division 2, or certified by the
department pursuant to Division 5 (commencing with Section 70001) of
Title 22 of the California Code of Regulations as a nurse assistant
or a home health aide, who provides direct patient care, so long as
the person is performing the test as an adjunct to the provision of
direct patient care by the person, is utilizing a point-of-care
laboratory testing device at a site for which a laboratory license or
registration has been issued, meets the minimum clinical laboratory
education, training, and experience requirements set forth in
regulations adopted by the department, and has demonstrated to the
satisfaction of the laboratory director that he or she is competent
in the operation of the point-of-care laboratory testing device for
each analyte to be reported.
   (B) Prior to being authorized by the laboratory director to
perform laboratory tests or examinations, testing personnel
identified in subparagraph (A) shall participate in a preceptor
program until they are able to perform the clinical laboratory tests
or examinations authorized in this section with results that are
deemed accurate and skills that are deemed competent by the
preceptor.  For the purposes of this section, a "preceptor program"
means an organized system that meets regulatory requirements in which
a preceptor provides and documents personal observation and critical
evaluation, including review of accuracy, reliability, and validity,
of laboratory testing performed.
   (12) Any other person within a physician office laboratory when
the test is performed under the supervision of the patient's
physician and surgeon or podiatrist who shall be accessible to the
laboratory to provide onsite, telephone, or electronic consultation
as needed, and shall:  (A) ensure that the person is performing test
methods as required for accurate and reliable tests; and (B) have
personal knowledge of the results of the clinical laboratory testing
or examination performed by that person before the test results are
reported from the laboratory.
   (13) A pharmacist, when ordering drug therapy-related laboratory
tests in compliance with clause (ii) of subparagraph (A) of paragraph
(5) of subdivision (a) of, or paragraph (6) of subdivision (a) of,
Section 4052.
   (c) Notwithstanding subdivision (b) of Section 1206, no person
shall perform clinical laboratory tests or examinations classified as
of high complexity under CLIA unless the clinical laboratory test or
examination is performed under the overall operation and
administration of the laboratory director, as described in Section
1209, including, but not limited to, documentation by the laboratory
director of the adequacy of the qualifications and competency of the
personnel, and the test is performed by any of the following persons:

   (1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
   (2) A licensed podiatrist or a licensed dentist when the results
of the tests can be lawfully utilized within his or her practice.
   (3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory when the test
or examination is within a specialty or subspecialty authorized by
the person's licensure.
   (4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code when the
test or examination is within a specialty or subspecialty authorized
by the person's certification.
   (5) A licensed physician assistant when authorized by a
supervising physician and surgeon in accordance with Section 3502 or
Section 3535.
   (6) A perfusionist when authorized by and performed in compliance
with Section 2590.
   (7) A respiratory care practitioner when authorized by and
performed in compliance with Chapter 8.3 (commencing with Section
3700).
   (8) A person performing nuclear medicine technology when
authorized by and performed in compliance with Article 6 (commencing
with Section 107115) of Chapter 4 of Part 1 of Division 104 of the
Health and Safety Code.
   (9) Any person when performing blood gas analysis in compliance
with Section 1245.
   (10) Any other person within a physician office laboratory when
the test is performed under the onsite supervision of the patient's
physician and surgeon or podiatrist who shall:  (A) ensure that the
person is performing test methods as required for accurate and
reliable tests; and (B) have personal knowledge of the results of
clinical laboratory testing or examination performed by that person
before the test results are reported from the laboratory.
   (d) Clinical laboratory examinations classified as
provider-performed microscopy under CLIA may be personally performed
using a brightfield or phase/contrast microscope by one of the
following practitioners:
   (1) A licensed physician and surgeon using the microscope during
the patient's visit on a specimen obtained from his or her own
patient or from a patient of a group medical practice of which the
physician is a member or employee.
   (2) A nurse midwife holding a certificate as specified by Section
2746.5, a licensed nurse practitioner as specified in Section 2835.5,
or a licensed physician assistant acting under the supervision of a
physician pursuant to Section 3502 using the microscope during the
patient's visit on a specimen obtained from his or her own patient or
from the patient of a clinic, group medical practice, or other
health care provider of which the certified nurse midwife, licensed
nurse practitioner, or licensed physician assistant is an employee.
   (3) A licensed dentist using the microscope during the patient's
visit on a specimen obtained from his or her own patient or from a
patient of a group dental practice of which the dentist is a member
or an employee.
  SEC. 2.  Section 1265 of the Business and Professions Code is
amended to read:
   1265.  (a) (1) A clinical laboratory performing clinical
laboratory tests or examinations classified as of moderate or of high
complexity under CLIA shall obtain a clinical laboratory license
pursuant to this chapter.  The department shall issue a clinical
laboratory license to any person who has applied for the license on
forms provided by the department and who is found to be in compliance
with this chapter and the regulations pertaining thereto.  No
clinical laboratory license shall be issued by the department unless
the clinical laboratory and its personnel meet the CLIA requirements
for laboratories performing tests or examinations classified as of
moderate or high complexity, or both.
   (2) A clinical laboratory performing clinical laboratory tests or
examinations subject to a certificate of waiver or a certificate of
provider-performed microscopy under CLIA, shall register with the
department.  The department shall issue a clinical laboratory
registration to any person who has applied for the registration on
forms provided by the department and is found to be in compliance
with this chapter, the regulations pertaining thereto, and the CLIA
requirements for either a certificate of waiver or a certificate of
provider-performed microscopy.
   (b) An application for a clinical laboratory license or
registration shall include the name or names of the owner or the
owners, the name or names of the laboratory director or directors,
the name and location of the laboratory, a list of the clinical
laboratory tests or examinations performed by the laboratory by name
and total number of test procedures and examinations performed
annually (excluding tests the laboratory may run for quality control,
quality assurance, or proficiency testing purposes).  The
application shall also include a list of the tests and the test kits,
methodologies, and laboratory equipment used, and the qualifications
(educational background, training, and experience) of the personnel
directing and supervising the laboratory and performing the
laboratory examinations and test procedures, and any other relevant
information as may be required by the department.  If the laboratory
is performing tests subject to a provider-performed microscopy
certificate, the name of the  provider or providers performing those
tests shall be included on the application.  Application shall be
made by the owners of the laboratory and the laboratory directors
prior to its opening.  A license or registration to conduct a
clinical laboratory if the owners are not the laboratory directors
shall be issued jointly to the owners and the laboratory directors
and the license or registration shall include any information as may
be required by the department.  The owners and laboratory directors
shall be severally and jointly responsible to the department for the
maintenance and conduct thereof or for any violations of this chapter
and regulations pertaining thereto.
   (c) The department shall not issue a license or registration until
it is satisfied that the clinical laboratory will be operated within
the spirit and intent of this chapter, that the owners and
laboratory directors are each of good moral character, and that the
granting of the license will not be in conflict with the interests of
public health.
   (d) A separate license or registration shall be obtained for each
laboratory location, with the following exceptions:
   (1) Laboratories that are not at a fixed location, that is,
laboratories that move from one testing site to another, such as
mobile units providing laboratory testing, health screening fairs, or
other temporary testing locations, may apply for and obtain one
license or registration for the designated primary site or home base,
using the address of that primary site.
   (2) Not-for-profit, or federal, state, or local government
laboratories that engage in limited (not more than a combination of
15 moderately complex or waived tests, as defined under CLIA, per
license) public health testing may apply for and obtain a single
license or registration.
   (3) Laboratories within a hospital that are located at contiguous
buildings on the same campus and under common direction, may file a
single application or multiple applications for a license or
registration of laboratory locations within the same campus or street
address.
   (4) Locations within a single street and city address that are
under common ownership may apply for and obtain a single license or
registration or multiple licenses or registrations, at the discretion
of the owner or owners.
   (e) A license or registration shall be automatically revoked in 30
days if there is a major change of laboratory directorship or
ownership.  The license or registration shall be valid for the
calendar year or remainder thereof for which it is issued unless
revoked or suspended.  If the department does not within 60 days
after the date of receipt of the application issue a license or
registration, it shall state the grounds and reasons for its refusal
in writing, serving a copy upon the applicant by certified mail
addressed to the applicant at his or her last known address.
   (f) The department shall be notified within 30 days of any change
in ownership, name, location, or laboratory directors.
  SEC. 3.  Section 1300 of the Business and Professions Code is
amended to read:
   1300.  The amount of application, registration, and license fees
under this chapter shall be as follows:
   (a) The application fee for a histocompatibility laboratory
director's, clinical laboratory bioanalyst's, clinical chemist's,
clinical microbiologist's, clinical laboratory toxicologist's,
clinical cytogeneticist's, or clinical molecular biologist's license
is thirty-eight dollars ($38).  This fee shall be sixty-three dollars
($63) commencing on July 1, 1983.
   (b) The annual renewal fee for a histocompatibility laboratory
director's, clinical laboratory bioanalyst's, clinical chemist's,
clinical microbiologist's, or clinical laboratory toxicologist's
license is thirty-eight dollars ($38).  This fee shall be sixty-three
dollars ($63) commencing on July 1, 1983.
   (c) The application fee for a clinical laboratory scientist's or
limited clinical laboratory scientist's license is twenty-three
dollars ($23).  This fee shall be thirty-eight dollars ($38)
commencing on July 1, 1983.
   (d) The application and annual renewal fee for a cytotechnologist'
s license shall be fifty dollars ($50) commencing on January 1, 1991.

   (e) The annual renewal fee for a clinical laboratory scientist's
or limited clinical laboratory scientist's license is fifteen dollars
($15).  This fee shall be twenty-five dollars ($25) commencing on
July 1, 1983.
   (f) The application fee for a clinical laboratory license is six
hundred dollars ($600).
   (g) The annual renewal fee for a clinical laboratory license is
five hundred fifty-seven dollars ($557).
   (h) The application fee for a certificate of accreditation issued
pursuant to Section 1223 is one hundred fifty dollars ($150).
   (i) The annual renewal fee for a certificate of accreditation
issued pursuant to Section 1223 is one hundred dollars ($100).
   (j) In addition, clinical laboratories providing cytology services
shall pay an annual fee that shall be set by the department in an
amount needed to meet but not exceed the department's costs of
proficiency testing and special site surveys for these laboratories,
and that shall be based upon the volume of cytologic slides examined
by a laboratory.  If the amount collected is less than or exceeds the
amount needed for these purposes, the amount of fees collected from
those laboratories in the following year shall be adjusted
accordingly.
   (k) The application fee for a trainee's license is eight dollars
($8).  This fee shall be thirteen dollars ($13) commencing on July 1,
1983.
   (l) The annual renewal fee for a trainee's license is five dollars
($5).  This fee shall be eight dollars ($8) commencing on July 1,
1983.
   (m) The application fee for a duplicate license is three dollars
($3).  This fee shall be five dollars ($5) commencing on July 1,
1983.
   (n) The delinquency fee is equal to the annual renewal fee.
   (o) The director may establish a fee for examinations required
under this chapter.  The fee shall not exceed the total cost to the
department in conducting the examination.
   (p) The certification and renewal fees for hemodialysis
technicians certified under subdivision (a) of Section 1247.6 shall
be fifty dollars ($50).  This subdivision shall become inoperative on
July 1, 2000, and shall have no effect after that date.
   (q) The annual fee for a clinical laboratory subject to
registration under paragraph (2) of subdivision (a) of Section 1265
and performing only those clinical laboratory tests or examinations
considered waived under CLIA is fifty dollars ($50).  The annual fee
for a clinical laboratory subject to registration under paragraph (2)
of subdivision (a) of Section 1265 and performing only
provider-performed microscopy, as defined under CLIA is seventy-five
dollars ($75). A clinical laboratory performing both waived and
provider-performed microscopy shall pay an annual registration fee of
seventy-five dollars ($75).
   (r) The costs of the department in conducting a complaint
investigation, imposing sanctions, or conducting a hearing under this
chapter shall be paid by the clinical laboratory.  The fee shall be
no greater than the fee the laboratory would pay under CLIA for the
same type of activities and shall not be payable if the clinical
laboratory would not be required to pay those fees under CLIA.
   (s) The state, a district, city, county, city and county, or other
political subdivision, or any public officer or body, shall be
subject to the payment of fees established pursuant to this chapter
or regulations adopted thereunder.
   (t) In addition to the payment of registration or licensure fees,
a clinical laboratory located outside the State of California shall
reimburse the department for travel and per diem to perform any
necessary onsite inspections at the clinical laboratory in order to
ensure compliance with this chapter.
   (u) Whenever a clinical laboratory has paid registration or
compliance fees, or both, to HCFA under CLIA for the same period of
time for which a license is issued under Section 1265, the fee
required for the clinical laboratory license under subdivision (f) or
(g), and as adjusted pursuant to Section 100450 of the Health and
Safety Code, shall be reduced by the percentage of the total of all
CLIA registration and compliance fees paid to HCFA by all California
laboratories that are made available to the department to carry out
its functions as a CLIA agent in the federal fiscal year immediately
prior to when the license fee is due.
